BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM LEFT SZ 5

    MDR report key: 20125992 · Received September 3, 2024

    Report

    Report Number
    1038671-2024-03221
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    November 14, 2023
    Report Date
    February 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001177
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 02-012-35-5011 - LOGIC TIBIA PS MOD INSRT SZ 5 11MM (2939289). 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T (2196984). 200-02-41 - THREE PEG PATELLA 41MM (3002224). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1038671-2023-02022, 1038671-2024-03220. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE FEMORAL LOOSENING AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED FEMORAL LOOSENING COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 115 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR AND ASEPTIC FEMORAL LOOSENING SECONDARY TO OSTEOLYSIS. THE PATIENT HAS HAD RECURRENT AND PERSISTENT EFFUSIONS WITH INCREASING WEIGHTBEARING PAIN. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900645 LOGIC FEMORAL PS CEM LEFT SZ 5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862001177

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R SEE H11